Product Wiki · Recalls · U.S. FDA — Device Enforcement

1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoSt — recall Z-2171-2015

U.S. FDA — Device Enforcement · United States · 2015-05-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2171-2015
Date of alert: 2015-05-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: American Medical Systems Innovation Center - Silicon Valley
Product category: device
Product type: Devices

Reported risk: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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